ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL— 510(k) K100547
Substantially EquivalentSeppim S.A.S.
FDA 510(k) clearance K100547 for ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL, Substantially Equivalent on 2011-05-19. Applicant: Seppim S.A.S.. Device class: 2.
Clearance details
- Applicant
- Seppim S.A.S.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
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